A Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Pancreatic Adenocarcinoma

A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

The main purpose of this study is to examine the safety of the study drug in patients with locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for this disease. Dendritic cells are cells that are present in the body's immune system that help your body fight disease.

Study Overview

• Status: Completed
• Conditions: Pancreatic Adenocarcinoma Non-resectable
• Intervention / Treatment: Biological: Poly-ICLC; Biological: dendritic cell

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Each of the following criteria must be met in order for a patient to be considered eligible for enrollment.

• Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is locally advanced and unresectable. Patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible.
• Patients must have measurable disease per RECIST 1.1. One or more tumors measurable on CT scan per RECIST 1.1. (Eisenhauer)
• Patients may have had prior cancer therapy. Patients do not need to demonstrate progression to be considered for this trial.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Age ≥ 18 years.
• Patient must have an expected life expectancy greater than 3 months.
• Signed, written IRB-approved informed consent.
• Bilirubin ≤ 3 times upper limit of normal (CTCAE Grade 2 baseline)
• AST (SGOT), ALT (SGPT) ≤ 3 x ULN (CTCAE Grade 1 baseline)
• Serum creatinine ≤1.5 XULN (CTCAE Grade 1 baseline)
• Acceptable hematologic status, defined as:
• Absolute neutrophil count ≥ 1000 cells/mm3
• Platelet count ≥ 75,000 (plt/mm3), (CTCAE Grade 1 baseline)
• Hemoglobin ≥ 9 g/dL.
• Urinalysis with no clinically significant abnormalities.
• PT and PTT ≤ 1.5 X ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT

Exclusion Criteria:

Each of the following criteria should not be present in order for the patient to be considered eligible for enrollment.

• Patients must not have metastatic disease. Patients with evidence of metastatic disease at the time of screening or prior to the administration of DC vaccination will be considered a screen failure and excluded from study.
• Prior surgery is allowed provided at least 14 days has elapsed between surgery and registration. Prior radiation/chemo is allowed provided that at least 28 days have elapsed since the last treatment.
• Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. Examples would include active acute or chronic infection requiring antibiotics, uncontrolled cardiovascular, endocrine, or infectious disease.
• Patient must not have clinically significant ascites.
• Patients must not have significant ongoing cardiac problems, myocardial infarction within the last six months, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia or congestive heart failure.
• Patients with known brain metastases are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms. If brainimaging studies are performed, they must be negative for disease. Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment.
• Due to the undetermined effect of this treatment regimen in patients with HIV-1 infection and the potential for serious interaction with anti-HIV medications, patients known to be infected with HIV are not eligible for this study.
• Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing. Women of child bearing potential must have a negative pregnancy test completed during study screening. Women and men of reproductive potential must have agreed to use an effective contraceptive method.
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dendritic cell and Poly-ICLC vaccination; Dendritic cell and Poly-ICLC vaccination will be administered directly into the tumor on Day 0 and Day 14 of Treatment Phase. Subjects will then have standard of care procedures along with injections of Poly-ICLC and dendritic cells for the remainder of the study.	Biological: Poly-ICLC; Biological: dendritic cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	Number of Participants With Adverse Events (AEs) Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.	from study consent to last treatment (Day 56)
Primary Objective	Determining the feasibility of generating dendritic cells and administering these cells as a vaccine to patients	from study consent to last treatment (Day 56)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome	Number of Participants With Tumor Response	Average three months Per Participant
Secondary Objective	Measure overall Survival	Post treatment

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 17, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Poly ICLC; dendritic cells; locally advanced, unresectable pancreatic adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Immunologic Factors; Interferon Inducers; Poly ICLC
• Other Study ID Numbers: 101778